A Trial of PX-12 in Patients With a Histologically or Cytologically Confirmed Diagnosis of Advanced or Metastatic Cancer

May 14, 2018 updated by: Cascadian Therapeutics Inc.

A Phase Ib Trial of PX-12 Administered as a 72-Hour Infusion Every 21 Days in Patients With a Histologically or Cytologically Confirmed Diagnosis of Advanced or Metastatic Cancer That is Refractory to Standard Treatment

PX-12 (1-methylpropyl 2-imidazolyl disulfide) is a novel small molecule inhibitor of thioredoxin-1, a small protein over-expressed in many human cancers that is associated with aggressive tumor proliferation, angiogenesis, and drug resistance. This study is being conducted to determine the maximally tolerated dose of PX-12 delivered as a 72-hour infusion over days 1, 2, and 3 of a 21-day cycle in patients with advanced or metastatic cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • TGen Clinical Research Services at Scottsdale Healthcare
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Texas
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed diagnosis of advanced or metastatic cancer or lymphoma whose tumors are refractory to standard therapy or for whom no standard therapy is available that increases survival by at least three months.
  2. Men and women at least 18 years of age.
  3. A predicted life expectancy of at least 12 weeks.
  4. ECOG performance status of 0-2 .
  5. Patients must have discontinued previous anticancer therapy and/or other investigational agents at least three weeks prior to treatment with PX-12 (six weeks for mitomycin C and nitrosureas) and recovered (grade 1 or less) from the toxic effects of that treatment. In the case of oral agents with a short half life, on a case by case basis, a minimum of a two week interval may be permitted.
  6. Patients must have discontinued any radiation therapy at least four weeks prior to treatment with PX-12 and have recovered from all radiation-related toxicities. Palliative radiation of 10 fractions or less is permitted and a four week interval is not necessary (also allowed during therapy).

  7. The patient has adequate hematologic function as defined by the following:

    platelets >100,000/μL; hemoglobin >9 g/dL (may be transfused to this level); ANC > 1,500 cells/μL.

  8. The patient has adequate hepatic function as defined by the following: bilirubin <2.0 mg/dL;aspartate aminotransaminase (AST/SGOT) & alanine aminotransferase (ALT/SGPT) <2.5 times (or up to five ULN for patients with liver metastases) institutional upper limit of normal (ULN). International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) within 1.5 times ULN unless subject is on coumadin.

  9. The patient has adequate renal function as defined by serum creatinine level

    ≤ 1.5 x ULN.

  10. Patient has signed informed consent.
  11. Patient is compliant with the study and in geographic proximity to allow adequate follow-up.
  12. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician

Exclusion Criteria:

  1. Patients with symptomatic pulmonary disease, e.g., active chronic obstructive/restrictive pulmonary disease, asthma, evidence of interstitial pneumonitis, pulmonary fibrosis, etc.
  2. Patients with history of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea.
  3. Patients that meet the Medicare criteria for receiving home oxygen or are on oxygen.
  4. Patients with a history of prior lung radiation.
  5. Patients with any active infection requiring i.v. antibiotics at study entry.
  6. Any serious concomitant systemic disorders that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
  7. Significant central nervous system or psychiatric disorder(s) that preclude the ability of the patient to provide informed consent.
  8. Known or suspected brain metastases that have not received adequate therapy. In the case of previously treated brain metastases, a minimum of four weeks interval between completion of radiation therapy and registration on study with radiologic evidence of stable or responding brain metastases is required. In the setting of previous CNS metastasectomy, adequate (minimum four week) recovery from surgery and/or radiation therapy should be documented.
  9. Major surgery within four weeks of treatment with PX-12.
  10. Patients with a history of seizures.
  11. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Patients who are breastfeeding or pregnant (confirmed by serum β-HCG within 10 days prior to the start of study treatment if applicable).
  13. Any condition that could jeopardize the safety of the patient and compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational Drug
Dose Escalation
Drug: PX-12
Intravenous infusion, dose escalation, infused over a 72 hour period on days 1, 2 and 3 of a 21-day cycle until progression or development of unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To determine the MTD of PX-12 delivered as a 72-hour infusion over days 1, 2, and 3 of a 21-day cycle
Time Frame: 21 days
21 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Evaluate the safety profile of PX-12
Time Frame: 42 days
42 days
When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Assess the pharmacodynamics of PX-12 using surrogate tissues obtained pre- and post-drug treatment
Time Frame: 42 days
42 days
When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Assess pharmacokinetic profiles of PX-12 in plasma samples
Time Frame: 42 days
42 days
When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Identify any antitumor activity of PX-12 in this patient population
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cascadian Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PX-12-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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